On Friday 20 December 2024 the MHRA have released the category lists following implementation of...
Category lists following implementation of the Windsor Framework
Further to my previous post, the MHRA have now updated the Category 1 list to include authorisations granted in December 2024. The MHRA state that this will be updated with new authorisation every two weeks. Currently I don't see a need to take a copy of this each time it is updated, more to use it as a reference (but I am happy to discuss with those who differ).
For those that haven't read this (and I would read, especially as it is quite short), an overview of the whole standard is as follows:
The Windsor Framework changes the regulation of certain medicinal products so that they can be licensed UK-wide under UK law. Other products will continue to be authorised under UK and applicable EU law.
New marketing authorisation (MA) applications and existing authorised products will be assigned to Category 1 or Category 2.
How Category 1 and Category 2 lists work
Products with more than one active substance will have multiple rows in the list. A decision ladder is provided to assist MA holders in verifying the category of each product.
(NB See the following guidance for details of category 1 and 2 classification:
https://lnkd.in/dHNi3ZyP)
Category 1 list
An initial list of products with authorisations in effect on 30 November 2024 was produced, followed by a list of products with authorisation in effect on 31 December 2024, assigned to Category 1.
Category 2 list
The Category 2 list will be published on this page in due course.
Categorisation from 1 January 2025
From 1 January 2025, the categorisation of new MAs will be included in the lists of new marketing authorisations published every two weeks.
Incorrect categorisation will be corrected during the procedure and will not lead to invalidation of the application.
https://lnkd.in/gmyxVPui
Further to my previous post, the MHRA have now updated the Category 1 list to include authorisations granted in December 2024. The MHRA state that this will be updated with new authorisation every two weeks. Currently I don't see a need to take a copy of this each time it is updated, more to use it as a reference (but I am happy to discuss with those who differ).
For those that haven't read this (and I would read, especially as it is quite short), an overview of the whole standard is as follows:
The Windsor Framework changes the regulation of certain medicinal products so that they can be licensed UK-wide under UK law. Other products will continue to be authorised under UK and applicable EU law.
New marketing authorisation (MA) applications and existing authorised products will be assigned to Category 1 or Category 2.
How Category 1 and Category 2 lists work
Products with more than one active substance will have multiple rows in the list. A decision ladder is provided to assist MA holders in verifying the category of each product.
(NB See the following guidance for details of category 1 and 2 classification:
https://lnkd.in/dHNi3ZyP)
Category 1 list
An initial list of products with authorisations in effect on 30 November 2024 was produced, followed by a list of products with authorisation in effect on 31 December 2024, assigned to Category 1.
Category 2 list
The Category 2 list will be published on this page in due course.
Categorisation from 1 January 2025
From 1 January 2025, the categorisation of new MAs will be included in the lists of new marketing authorisations published every two weeks.
Incorrect categorisation will be corrected during the procedure and will not lead to invalidation of the application.
https://lnkd.in/gmyxVPui